MAUDE Adverse Event Report: RAEL, INC. ACNE PIMPLE HEALING PATCH; DRESSING, WOUND, HYDROPHILIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Irritation (2076)

Event Date 09/01/2019

Event Type  Injury  

Event Description

Hello, i purchased this product (b)(6) because it promised to heal my acne.But when i tried the product, it did not have any effect for me.In fact, it further irritated my skin.

• Brand Name: ACNE PIMPLE HEALING PATCH
• Type of Device: DRESSING, WOUND, HYDROPHILIC
• Manufacturer (Section D): RAEL, INC.
• MDR Report Key: 9146269
• MDR Text Key: 161190807
• Report Number: MW5090162
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 90